SUPERa Stenting After SUBintimal Crossing of TASC C-D Femoro-popliteal Lesions in CLI Patients
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/16/2018 |
| Start Date: | March 7, 2018 |
| End Date: | March 31, 2021 |
| Contact: | Maria Salomone, MD |
| Email: | m.salomone@endocorelab.org |
| Phone: | +39 3357378767 |
The study will evaluate the safety and efficacy of subintimal Supera stenting in complex de
novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be
performed based on a rigorous sample size calculation, which will allow us to have the
statistical power to validate our conclusions and therefore establish the generalizability of
this strategy.
novo or re-occlusive CTO (TASC C-D) lesions in patients with CLI. This study will be
performed based on a rigorous sample size calculation, which will allow us to have the
statistical power to validate our conclusions and therefore establish the generalizability of
this strategy.
The present study is designed as a prospective, open label, observational study.
The study will collect information about the medical care patients receive during their
planned procedure. No additional testing or procedures will be done.
Patients elected for endovascular revascularization with SuperSub strategy will be asked
their written consent to the use of their personal data.
Revascularization will be performed as per standard procedure of the sites. After discharge
all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months
(±30 days) and 24 months (±30 days). Angiographic follow-up will be performed only in
symptomatic patients, as clinically indicated and with the aim for a new treatment.
The study will collect information about the medical care patients receive during their
planned procedure. No additional testing or procedures will be done.
Patients elected for endovascular revascularization with SuperSub strategy will be asked
their written consent to the use of their personal data.
Revascularization will be performed as per standard procedure of the sites. After discharge
all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months
(±30 days) and 24 months (±30 days). Angiographic follow-up will be performed only in
symptomatic patients, as clinically indicated and with the aim for a new treatment.
Inclusion Criteria:
General Inclusion Criteria:
- Patients with CLI and TASC C-D Fem-Pop CTO's
- Age ≥18 years
- Patient has signed an approved consent form
- Patients without previous stenting of the Fem-Pop segment
Angiographic Inclusion Criteria:
- Patent and hemodynamically normal iliac and common femoral arteries.
- At least one patent and healthy tibial vessel runoff to the foot.
- Patient has documented TASC C or D Fem-Pop CTO's prior to the study procedure
- Rutherford Category 4, 5 or 6
- Subintimal crossing of the occluded Fem-Pop vessels
- Supera Stenting From healthy to healthy arterial segment.
Exclusion Criteria:
- Patient unwilling or unlikely to comply with Follow-Up schedule
- Endoluminal crossing of the CTO
- Inability to stent from "healthy to healthy" arterial segments.
- Inability to re-enter within the pre-specified Ideal Landing Zone (IDL)
We found this trial at
2
sites
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5900 Byron Center Ave SW
Wyoming, Michigan 49519
Wyoming, Michigan 49519
(616) 252-7200
Phone: 616-340-4730
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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